Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET

Summary

Participation Requirements

Description

NUMBER OF PATIENTS: 200 patients INCLUSION PERIOD: 33 months STUDY DURATION: 57 months MAIN EVALUATION Primary endpoints • Week 10-54: proportion of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54 Data base lock, data analysis and display (publication) will happen when all i...

NUMBER OF PATIENTS: 200 patients INCLUSION PERIOD: 33 months STUDY DURATION: 57 months MAIN EVALUATION Primary endpoints • Week 10-54: proportion of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54 Data base lock, data analysis and display (publication) will happen when all included subjects have completed the 108-week visit. SECONDARY EVALUATION For all included patients: Phase II (week 54-108): proportion of patients in CCR with MH (endoscopic Mayo score of 0 or 1) at week 108, after discontinuation or dose de-escalation (from 100 to 50 mg) of golimumab treatment at year 1 in the subgroup of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54 Factors associated with treatment success (see primary endpoint) Efficacy of dose optimization in patients who loose response between week 10 and 54 Clinical remission at week 54 • Clinical remission at week 108 • Partial MAYO score at week 54 and 108 • PRO2 (Partial Mayo minus PGA) at week 54 and 108 • CCR between study inclusion and week 54 and 108 • Steroid-free clinical remission at week 54 and 108 • MH (endoscopic score MAYO 0-1) at week 54 and 108 • Changes in faecal calprotectin levels from baseline to week 54 and 108 • Colectomy between W0 and W54 and 108 UC-related hospitalizations throughout the trial • Histological remission9 at W54 and 108 PRO: Fatigue (FACIT), disability (IBD Disability index), QoL (SHS-IBD VAS) PK data (golimumab trough levels and antibodies against golimumab) Proportion of late responders being in Clinical Response from week 18 to week 54 and with MH at week 54 following treatment intensification in Maintenance Phase For the subgroup of patients who are primary non-responders to golimumab at week 10, we will assess the efficacy of treatment optimization, including the percentage of patients achieving continuous clinical response and endoscopic remission at one year.

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